National authorisations

Make sure that you have everything you need before making your application.

You will see what you need in these places:

The Biocides Submission Manual (BSM) 'Technical Guide: How to prepare a biocides dossier'.

The Biocides Submission Manual (BSM) 'Technical Guide: How to use the SPC Editor’.

The Biocides Submission Manual (BSM) ‘Technical Guide: How to use R4BP 3'

The Biocides Submission Manual (BSM) ‘Application instructions: How to submit an application for National Authorisation '.

The "Supporting Documents" table from ECHA's website. Make sure that you use the latest document template.

The ‘Guidance on information requirements for Biocides'

The Practical Guides.

Important note for national authorisation renewal submissions

When you apply for a national authorisation renewal (NA-RNL) please make sure that you attach the correct supporting document. The supporting document to use depends on whether you are renewing:

a single authorisation or;

two or more authorisations linked by mutual recognition.

When you submit a renewal for two or more national authorisations, make sure that you identify each and every asset and enter them in only one supporting document. The supporting document needs to include all assets that form part of the same group for each and every application.

When you prepare a renewal for two or more national authorisations linked by mutual recognition, it is vital that you organise amongst the asset owners which assets will be renewed and the distribution of the submission work.

Please contact the ECHA Helpdesk or your national helpdesk if you have any queries concerning your application for a national authorisation renewal.

Submit your applications

Authorisation of biocidal products

Prepare your IUCLID dossier.

From the ‘NEW APPLICATION' tab, select ‘NA-APP – Application for national authorisation' to launch the application ‘wizard', which will guide you through the various steps of the submission process.

Log into R4BP 3.

You can apply for more than one Mutual recognition(s) in parallel at the same time. You can submit simultaneous applications to every concerned Member State by making a selection in the relevant tick boxes in the ‘Select authorities’ step. You can also initiate the Mutual recognition(s) in parallel at a later stage. Please refer to the specific section below for further information.

Mutual recognition in parallel

Draft your SPC file from the SPC of the reference case.

Log into R4BP 3.

You can launch your application in three different ways:

During the submission of an application for national authorisation, in the ‘Select authorities' step, as explained in the section above.

From the ‘NEW APPLICATION' tab: select ‘NA-MRP – Mutual recognition in parallel' and enter the reference number (the national authorisation case number of the biocidal product you want to have recognised in parallel).

From the ‘CASES' tab: search for the relevant national authorisation case you want to have recognised in parallel. Click on the case number and from the details page launch your application by clicking ‘Create new case' for ‘NA-MRP – Mutual recognition in parallel'.

The application ‘wizard' will guide you through the various steps of the submission process.

Mutual recognition in sequence

Draft your SPC file from the authorised SPC of the reference asset.

Log into R4BP 3.

You can launch your application in two different ways:

From the ‘NEW APPLICATION' tab; select ‘NA-MRS – Mutual recognition in sequence' and enter the reference number (the national authorisation asset number of the biocidal product you want to have mutually recognised).

From the ‘ASSETS' tab, search for the relevant national authorisation asset you want to have mutually recognised. Click on the asset number and from the details page launch your application by clicking ‘Create new case' for ‘NA-MRS – Mutual recognition in sequence'.

The application ‘wizard' will guide you through the various steps of the submission process.

Authorisation of the same biocidal product (pending and authorised)

Create your SPC file from the authorised SPC of the reference family case or asset, using specific functionality in the SPC Editor – Apply for a same product.

Log into R4BP 3.

From the ‘NEW APPLICATION' tab, select ‘NA-BBP – National authorisation of the same biocidal product (pending)' and enter the reference number (the national authorisation or mutual recognition in parallel case number of the reference biocidal product) or ‘NA-BBS – National authorisation of the same biocidal product (authorised)' and enter the reference number (the national authorisation asset number of the reference biocidal product) to launch the application ‘wizard'.

The application ‘wizard' will guide you through the various steps of the submission process.

From the ‘ASSETS' tab, search for the relevant national authorisation asset you wish to renew. Click on the asset number and from the details page launch your application by clicking ‘Create new case' for ‘NA-RNL - Application for renewal of national authorisation'. The application ‘wizard' will guide you through the various steps of the submission process.

If you want to initiate the renewal of a single national authorisation(s) under Article 31 of the BPR, your receiving Member State is already given and you should leave the other asset(s) proposed in the ‘Grouping of assets' step (if any) unselected. Submit your application with the supporting document ‘Renewal of a single national authorisation'.

If you want to initiate the grouped renewal of several national authorisation(s) linked by mutual recognition under Article 2 of Regulation (EU) No 492/2014, you should:

List all the assets to be renewed together in the supporting document ‘Grouped renewal of several authorisations linked by mutual recognition' that should be attached to your submission,

Among the assets you have access to, select one which has been granted by the Member State you have chosen as reference Member State for the renewal and initiate the renewal from this asset; N.B.: in case you do not have access to any asset granted by the selected reference Member State, select any other asset and initiate the renewal from this asset, .

Select all the appropriate asset(s) by ticking the corresponding boxes in the ‘Grouping of assets' step; by doing this, simultaneous applications will be sent to the Member States corresponding to the selected assets,

If you are not able to select all the assets listed in the supporting document (i.e. the assets which should be renewed together), the assets not covered by your submission will have to be covered by other (additional) submission(s) which should all contain the same supporting document in order to ensure the linking, N.B.: the additional submission(s) can be made either by you or by other companies, depending on who has access to the assets to be renewed which have not been covered by your submission.

If you want to include a new NA-RNL case in your grouped renewal of several national authorisations, you should search for your reference case. The status should be ‘in progress’ or ‘suspended’. Click on ‘create new case’ in the submission details page to launch the application wizard.

Classification of a change to a product authorisation

Log into R4BP 3.

From the ‘NEW APPLICATION' tab, select ‘CC-APP – Classification of a change to a product authorisation' to launch the application ‘wizard', which will guide you through the various steps of the submission process.

Administrative change on request

Draft your SPC file from the authorised SPC of the reference asset.

Log into R4BP 3.

From the ‘ASSETS' tab, search for the relevant national authorisation asset for which you wish to request a change. Click on the asset number and from the details page launch your application by clicking ‘Create new case' for ‘NA-ADC - National authorisation administrative change on request'. The application ‘wizard' will guide you through the various steps of the submission process. If the changes are sought in more than one market area, you can submit simultaneous applications to every concerned Member state by making a selection in the relevant tick boxes in in the ‘Grouping of assets' step.

If one or more of your asset(s) where you are the owner of, or you have rightful nomination for, is not visible in the ‘Grouping of assets' step:

Indicate in the supporting document of your current application all asset number(s) affected by the change - i.e. including the asset(s) which were not presented by the wizard – note the corresponding asset numbers

Submit your notification/application, with the supporting document from step 1, for the assets that you have selected from the list visible to you in the wizard. Initiate a new separate NA-ADC follow up application for each of your missing asset(s) (the assets not presented by the wizard but affected by the change), and include the same supporting document submitted in your previous application (step 1). The reference Member State indicated in the supporting document must be the same as the one for earlier submission.

Submit your follow up application(s)

If the changes are not sought in the Member State which originally evaluated your application for authorisation of the biocidal product, or if you wish to change the reference Member State, you will need to initiate the submission from the asset which has been granted by your chosen new reference Member State.

Minor and major change on request

Prepare your IUCLID dossier.

Log into R4BP 3.

From the ‘ASSETS' tab, search for the relevant national authorisation asset for which you wish to request a change. Click on the asset number and from the details page launch your application by clicking ‘Create new case' for ‘NA-MIC - National authorisation minor change on request' or ‘NA-MAC - National authorisation major change on request'. The application ‘wizard' will guide you through the various steps of the submission process.

If the changes are sought in more than one market area, you can submit simultaneous applications to every concerned Member State by making a selection in the relevant tick boxes in in the ‘Grouping of assets' step.

If one or more of your asset(s) where you are the owner of, or you have rightful nomination for, is not visible in the ‘Grouping of assets' step:

Indicate in the supporting document of your current application all asset number(s) affected by the change - i.e. including the asset(s) which were not presented by the wizard – note the corresponding asset numbers

Submit your notification/application, with the supporting document from step 1, for the assets that you have selected from the list visible to you in the wizard. Initiate a new separate NA-MIC or NA-MAC follow up application for each of your missing asset(s) (the assets not presented by the wizard but affected by the change), and include the same supporting document submitted in your previous application (step 1). The reference Member State indicated in the supporting document must be the same as the one for earlier submission.

Submit your follow up application(s)

If you want to include a new NA-MIC or NA-MAC case in your grouped submission, you should search for your reference case. The status should be ‘in progress’ or ‘suspended’. Click on ‘create new case’ in the submission details page to launch the application wizard.

If the changes are not sought in the Member State which originally evaluated your application for authorisation of the biocidal product, or if you wish to change the reference Member State, you will need to start the submission from the asset which has been granted by your chosen new reference Member State.

Merge of product authorisation(s) in one product family

Draft your SPC file from the authorised SPC of the reference asset.

Log into R4BP 3.

From the ‘NEW APPLICATION' tab, select ‘NA-MRG – Merge of product authorisation(s) in one product family' and enter the reference number (the national authorisation asset number of the reference biocidal product you want to merge into a product family) to launch the application ‘wizard' which will guide you through the various steps of the submission process.

Transfer of authorisation

The owner of a national authorisation asset must first initiate a transfer process in R4BP 3, this is done in the ‘Delegation/ Nomination’ tab of the asset. Once the owner has delegated the asset, you can start the acceptance.

Draft your SPC file from the authorised SPC of the obtainable asset.

Log into R4BP 3.

From the ‘ASSET' tab, search for the relevant national authorisation asset. Click on the asset number and from the details page click ‘Accept Asset Transfer'. The application ‘wizard' will guide you through the various steps of the process.

Authorisation cancellation on request

Log into R4BP 3.

From the ‘ASSETS’ tab, search for the specific asset number by filling in some search criterion. Clicking on the asset number hyperlink in the ‘Assets list’ will open a details page for that specific asset. On this page, click ‘Create new case’ and a list of application types available for that asset will appear. From this list, you can launch the wizard by selecting ‘NA-CCL – National authorisation cancellation on request’. It is important to note that when creating a member cancellation you have to start by selecting first the member asset.

The application ‘wizard’ will guide you through the various steps of the submission process.

Notification for a product in a product family

Create your SPC file from the authorised SPC of the reference family asset, using specific functionality in the SPC Editor – ‘Notify a product’.

Log into R4BP 3.

From the ‘ASSETS' tab, search for the relevant national authorisation asset. Click on the asset number and from the details page launch your application by clicking ‘Create new case' for ‘NA-NPF - Notification of product in product family for national authorisation'. The application ‘wizard' will guide you through the various steps of the submission process.

Notification of unexpected or adverse effect

Log into R4BP 3.

From the ‘ASSETS' tab, search for the relevant national authorisation asset for which you wish to notify unexpected or adverse effect.. Click on the asset number and from the details page launch your application by clicking ‘Create new case' for ‘NE-NOT - Notification of unexpected or adverse effect for national authorisation'. The application ‘wizard' will guide you through the various steps of the submission process.

Notification of experiment or test

Prepare your IUCLID dossier.

Log into R4BP 3.

From the ‘NEW APPLICATION' tab, select ‘ET-NOT – Notification of experiment or test' to launch the application ‘wizard', which will guide you through the various steps of the submission process.

Parallel trade

Log into R4BP 3.

From the ‘NEW APPLICATION' tab, select ‘PP-APP – Parallel trade' and enter the reference numbers (the national authorisation asset number in the Member State of origin and the national authorisation asset number in the Member State of introduction) to launch the application ‘wizard', which will guide you through the various steps of the submission process.

Inquire to share data for a biocidal product

Log into R4BP 3.

From the ‘NEW APPLICATION' tab, select ‘IN-REB – Inquire to share data (for biocidal product)' and enter the reference number (the national authorisation asset number of the reference biocidal product) to launch the application ‘wizard', which will guide you through the various steps of the submission process.

Follow up your applications

Important – make a note of your submission number. You will need it for further reference.

Important - check your tasks and messages in R4BP 3 regularly. They can include:

Requests for more information. These are important because if you fail to complete the task by the deadline, your application may be rejected.

Invoices, which have a 30-day deadline for payment. If you fail to pay the fee within the deadline, you application will be rejected.

Results of the ECHA format check.

Results of the acceptance step.

Withdraw your application

If you don’t want to proceed with one of your application, you are allowed to withdraw it from the system: